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OpenTrials
Completed

NCT Number: NCT02492438

13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients

To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dienst Nefrologie, OLV Ziekenhuis, Aalst, Belgium

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About this study

The immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • they are under chronic dialysis treatment
  • are 50 years or older and not pregnant
  • have no immediate life threatening conditions
  • are not allergic to one of the compounds of the vaccine
  • have a known pneumococcal vaccination status
  • give their informed consent.

Exclusion criteria

Patients not fulfilling the inclusion criteria.

Treatment and study plan

PPV23 vaccination or PCV13 vaccination

Biological

Other names: Prevenar 13, Pneumovac 23

Primary outcomes

  1. Antibody response after vaccination to involved serotypes measured by OPA and ELISA

    Time frame: 52 weeks after vaccination

Secondary outcomes

  1. record of side effects of vaccination

    Time frame: first week after vaccination

  2. Antibody response after vaccination to involved serotypes measured by OPA and ELISA

    Time frame: 4 weeks after vaccination

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Collaborators

  • Pfizer

Registry information

Official study title

Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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